(56 days)
A PATIENT EXAMINATION GLOVE IS A DISPOSABLE DEVICE INTENDED FOR MEDICAL PURPOSE THAT IS WORN ON THE EXAMINER'S HAND OR FINGER TO PREVENT CONTAMINATION BETWEEN PATIENT AND EXAMINER.
POWDER FREE COPOLYMER NITRILE MEDICAL EXAMINATION GLOVE, COLORED.
This looks like a letter from the FDA regarding a 510(k) premarket notification for examination gloves, not an AI/ML device or a study related to acceptance criteria.
The document discusses:
- K990299 Powder-Free Copolymer Nitrile Medical Examination Gloves.
- The FDA's determination that the device is substantially equivalent to a predicate device.
- General controls provisions of the Act (annual registration, listing of devices, good manufacturing practice, labeling, etc.).
- Information on labeling regulations, promotion and advertising, and other responsibilities under the Act.
- The "Indications for Use" statement for the gloves, which states they are a disposable device intended for medical purposes to prevent contamination between patient and examiner.
Therefore, the requested information about acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training data for an AI/ML device cannot be extracted from this document, as it is completely unrelated to such a device or study.
§ 880.6250 Non-powdered patient examination glove.
(a)
Identification. A non-powdered patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. A non-powdered patient examination glove does not incorporate powder for purposes other than manufacturing. The final finished glove includes only residual powder from manufacturing.(b)
Classification. Class I (general controls). The device, when it is a finger cot, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 880.9.